Recall archive / FDA drug enforcement
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Me... — FDA record D-0557-2024
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 28, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02
- Reason
- cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
- Classification
- Class II
- Recalling firm
- Denison Pharmaceuticals, LLC
- Quantity
- 113,544 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0557-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #: 0855, Exp. 8/31/ 2025 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 26, 2024
- Recall initiation date
- May 28, 2024
- Center classification date
- Jun 17, 2024
- Termination date
- Aug 26, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.